The purpose of this study is to examine the safety and effectiveness of USL261 for the outpatient treatment of seizure clusters.

Treatment Success is defined as achieving both of the following: 1) termination of seizure(s) within 10 minutes after study drug administration, and 2) no recurrence of seizure(s) beginning 10 minutes after study drug administration to 6 hours after study drug administration.

There is a compelling need for prospective, properly controlled studies in women with epilepsy (WWE) during pregnancy to improve maternal and child outcomes. The proposed investigations are pertinent to the National Institute of Neurological Disorders and Stroke Epilepsy Research Benchmarks and will address multiple gaps in our knowledge noted by the recent American Academy of Neurology guidelines. This multicenter investigation will employ a prospective, observational, parallel-group, cohort design with an established research team.

The specific aims are to:

1. Determine if women with epilepsy have increased seizures during pregnancy and delineate the contributing factors;

2. Determine if C-section rate is increased in women with epilepsy and delineate contributing factors;

3. Determine if women with epilepsy have an increased risk for depression during pregnancy and post-partum period and characterize risks factors;

4. Determine the long-term effects of in utero antiepileptic drug exposure on verbal intellectual abilities and other neurobehavioral outcomes in the children of women with epilepsy;

5. Determine if small for gestation age and other adverse neonatal outcomes are increased in children of women with epilepsy;

An overall goal of the proposed research is to establish the relationship between antiepileptic drug exposure and outcomes in the mother and child as well as describe and explain the variability in antiepileptic drug exposure and response.

Anticonvulsant blood levels (ABLs) and area-under-the-concentration-time-curves (AUCs) will be used as direct measures of drug exposure. The results will enable clinicians to prospectively calculate individual dosing regimens for the mother in order to optimize dosing and limit unnecessary drug exposure to the child. In addition, genetic samples will be collected, which will provide a valuable resource for future pharmacogenetics studies to further delineate individual variability across patients.

The University of Arizona - Department of Neurology is conducting this research study to find out whether a new procedure, called Visualase Thermal Therapy System, is a safe and minimally invasive treatment option for patients with epileptic lesions. Thermal Therapy is the use of laser light to destroy the affected tissue through heat.

The Visualase Thermal Therapy System uses a technique called laser interstitial thermal therapy or LITT to heat and "kill" soft tissues inside the body. A thin fiber optic applicator is inserted into the center of the target tissue and delivery of laser energy causes the tissue to heat up, literally "cooking" it from the inside out. The Visualase procedure is done while the patient is inside of a magnetic resonance imaging (MRI) machine. While the laser energy is being delivered, MRI pictures are taken and converted into maps of the heat that is being delivered. In this way, the doctor can monitor the progress of the LITT procedure and make sure that only the target tissue is destroyed.

This study is currently being done at Texas Children's Hospital in Houston, TX. The following Internet links are for 2 separate news stories regarding this research study. Both stories focus on one patient's case, a 9 year old boy, who suffered from two types of seizures that disrupted everything in his life. Both news stories explain the procedure and the outcome that the patient experienced after undergoing this research procedure. The news story from CBS News offers a very informative illustration of the actual procedure.